FDA Layoffs: Impact on Medical Device Review and Patient Safety
Over the February 15-16, 2025 weekend, the new U.S. administration laid off a substantial number of FDA reviewers from the Center for Device and Radiological Health (CDRH), the branch that reviews the safety and efficacy of new medical devices, including hip and knee implants, cardiovascular and respiratory devices, ophthalmological treatments, wound care, and thousands of […]
Quantifying Rapid Rheological Changes
Blood vessel with hemostatic agent In the world of material science and product design, understanding and measuring rapid rheological transitions is crucial. These transitions, which can be triggered by various stimuli such as UV light, electrical fields, or chemical interactions, play a significant role in applications ranging from hemostatic agents to 3D printing materials. While […]
FDA’s Regulatory Freeze: Implications for Medical Device Standards and Patient Safety
Medical device development relies heavily on standards to ensure patient safety, efficacy, and regulatory compliance. Organizations such as ASTM, AAMI/ISO, and USP establish critical test methods to ensure adequate cleaning and sterility, mechanical performance, biocompatibility, and material integrity. These standards streamline innovation while safeguarding patients, reducing redundant testing, and maintaining U.S. competitiveness in global markets. […]